Who is sponsoring NCT00330681?

NCT00330681 is sponsored by Tanabe Pharma Corporation.

What condition does NCT00330681 study?

NCT00330681 studies Amyotrophic Lateral Sclerosis (ALS).

What drugs are being tested in NCT00330681?

Interventions: MCI-186, Placebo of MCI-186.

What is the status of NCT00330681?

NCT00330681 is currently COMPLETED.

Last reviewed 2025-12-15 · How we verify

A Confirmatory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-blind, Parallel-group, Placebo-controlled Manner.

NCT00330681 Phase 3 COMPLETED Results posted

The primary objective of this study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip once a day in patients with ALS based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-controlled manner. And in addition, this study will be performed to examine the safety of MCI-186 to ALS patients.

Details

Lead sponsor	Tanabe Pharma Corporation
Phase	Phase 3
Status	COMPLETED
Enrolment	206
Start date	2006-05
Completion	2008-09

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Interventions

MCI-186
Placebo of MCI-186

Primary outcomes

Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks — baseline and 24 weeks
ALSFRS-R Score: 0=worst; 48=best